We inspected your firm, Italco Food Products, Inc., located at 1340 South Cherokee Street, Denver, Colorado, on January 20-22, 25-26, 28, 2010. Our inspection found that your firm has serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 [21 CFR Part 123]. In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR Part 123 renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. §342(a). Accordingly, your vacuum packaged smoked salmon, smoked trout, and pickled seafood salad in oil are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP Regulations through links in FDA's home page at www.fda.gov.

The deviations that were found during the inspection were as follows:

1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for vacuum packaged smoked salmon, smoked trout, and pickled seafood salad in oil to control the hazard of pathogen growth and toxin formation from the growth of Clostridium botulinum.

We received your written response February 16, 2010 to the FDA 483, Objectionable Observations. Our review of the information provided in that response reveals that it is inadequate. While you state that you will begin the HACCP program, you have not, as of this time, provided a HACCP plan (or plans) to address the hazards and controls associated with the above mentioned products.

You may find the Act, the seafood HACCP regulation, and FDA's, Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

When conducting your hazard analysis, your firm should assess those steps that are reasonably likely to result in Clostridium botulinum growth and toxin formation due to time/temperature abuse. For example, receipt of refrigerated products will likely be critical to ensure that proper temperatures were maintained during the transit period to your facility. In addition, refrigerated finished product storage will likely be critical to ensure proper temperatures are maintained during extended storage periods. FDA recommends the use of equipment capable of monitoring and recording refrigerated temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature records and a daily check of the equipment.

We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as your HACCP plans, any records required to document your HACCP plan including temperature monitoring records, corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter may not list all of the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP Regulations, and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.